Methods, systems, and devices for positioning sutures for closing an opening in tissue

ABSTRACT

A closure system for closing an opening in tissue, the closure system including a closure device and a knot replacement device configured to position a suture lock on a suture. The closure device includes a housing, a needle actuation handle cooperating with the housing, a first hollow needle selectively movable by the needle actuation handle and operatively cooperating with a suture anchor frictionally engaged with a slot and a lumen of the first hollow needle and coupled to a suture. A portion of the suture anchor rests along an outer surface of the first hollow needle as the first hollow needle is advanced through tissue adjacent the opening.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/510,564, filed Jul. 12, 2019, the entire contents of which areincorporated by reference herein.

BACKGROUND OF THE INVENTION 1. The Field of the Invention

The present disclosure relates generally to medical devices and theirmethods of use. In particular, the present disclosure relates to systemsand devices for closing an opening in tissue and corresponding methodsof use.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed transluminally, where a catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access which is usually established usingthe well-known Seldinger technique, as described, for example, inWilliam Grossman's “Cardiac Catheterization and Angiography,” 3rd Ed.,Lea and Febiger, Philadelphia, 1986, incorporated herein by reference.

Upon completing the procedure, and vascular access is no longer needed,the devices and introducer sheath would be removed, leaving a puncturesite in the vessel wall. Traditionally, external pressure would beapplied to the puncture site until clotting and wound sealing occur;however, the patient must remain bedridden for a substantial periodafter clotting to ensure closure of the wound. This procedure may alsobe time consuming and expensive, requiring as much as an hour of aphysician's or nurse's time. It is also uncomfortable for the patientand requires that the patient remain immobilized in the operating room,catheter lab, or holding area. In addition, a risk of hematoma existsfrom bleeding before hemostasis occurs. Although systems may beavailable to close the opening in tissue, such as a puncture providingaccess to the patient's vasculature, they provide limited control andflexibility to the operator, which may lead to improper or undesirableclosure of the tissue opening, such as the puncture site.

BRIEF SUMMARY OF THE INVENTION

Various embodiments of a closure device for closing an opening in tissueare disclosed herein. Also disclosed are various embodiments methods forpositioning, deploying, and removing the closure device associated withclosing the opening.

In one configuration, a closure device for closing an opening in tissueincludes a needle actuation handle cooperating with a housing, a hollowneedle is selectively movable by the needle actuation handle, the needleincluding a slot extending proximally from a distal end of the needle,and a suture anchor positioned within and selectively releasable fromthe slot and coupled to a suture. A portion of the suture anchor extendsproximally along an outer surface of the needle as the needle isadvanced through tissue adjacent the opening.

In one configuration, the closure device includes a locking memberselectively disposed about a body of a needle actuation handle distal ahandle portion.

In one configuration, the closure device includes the needle actuationhandle being biased proximally from the housing.

In one configuration, the closure device includes the suture anchorhaving two legs extending transversely to the suture in the pre-deployedstate and a deployed state.

In one configuration, the closure device includes the suture anchorhaving two legs extending transversely to the suture in the pre-deployedstate and a deployed state, the two legs extending proximally along theouter surface of the needle in the pre-deployed state.

In one configuration, the closure device for closing an opening intissue includes a housing, a needle actuation handle cooperating withthe housing, a hollow needle selectively movable by the needle actuationhandle, the needle including a slot extending proximally from a distalend of the needle and communicating with a lumen of the hollow that isconfigured to receive a suture, and a suture anchor positioned withinand selectively releasable from the slot and coupled to the suture. Thesuture anchor, at a position proximal the distal end of the needle,extends proximally along an outer surface of the needle as the needle isadvanced through tissue adjacent the opening.

In one configuration, the closure device includes a suture storagereceptacle disposed proximal a proximal end of a needle actuationhandle, the suture extending from the distal end of the needle to thesuture storage receptacle.

In one configuration, the closure device includes a suture storagereceptacle that has a spiral form.

In one configuration, the closure device includes a distal end of theneedle having a cutting edge.

In one configuration, the closure device includes a bleed back locator.

In one configuration, the closure device includes a locking memberselectively disposed about a body of the needle actuation handle distala handle portion.

In one configuration, the closure device includes a locking memberhaving a locking channel receiving the body and a biasing memberseparating the handle portion and the housing.

In one configuration, the closure device includes a tether connectingthe locking member to the housing.

In one configuration, the closure device includes a needle actuationhandle and the needles are selectively slidable in both aproximal-to-distal direction and a distal-to-proximal direction, withthe needle actuation handle and the needle being selectively removablefrom the housing.

In one configuration, the closure device includes a guidewire lumenending from a proximal exit port towards a distal inlet port that isdistal the distal end of the needle in the pre-deployed state.

In one configuration, a method is disclosed, the method includingpositioning a distal end of a closing device through a tissue opening,the closing device having a housing from which a needle is advanceable,advancing the needle from the housing towards tissue adjacent to thetissue opening, the needle having a slot accommodating a suture anchorand a lumen accommodating a suture, the suture anchor having two legsextending transversely from the anchor in a pre-deployed state and adeployed state, and advancing the needle through the tissue adjacent tothe tissue opening, the two legs extending proximally along an outersurface of the needle as the needle is advanced through tissue adjacentthe opening;

In one configuration, the method includes proximally retracting theneedle following advancing the needle through the tissue to overcomeengagement between the suture anchor and walls of the slot.

In one configuration, the method includes twisting the suture.

In one configuration, the method includes following twisting the suture,positioning a suture lock on the suture.

In one configuration, the method includes cutting the suture.

These and other objects and features of the present invention willbecome more fully apparent from the following description and appendedclaims or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent invention, a more particular description of the invention willbe rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only illustrated embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a plan view of a tissue opening closure deviceaccording to an embodiment of the present invention.

FIG. 2 illustrates the plan view of the tissue opening closure device ofFIG. 1 within a detached locking member.

FIG. 3 illustrates a cross-section view of a portion of the tissueopening closure device of FIG. 1.

FIG. 4A illustrates another cross-sectional view of a portion of thetissue opening closure device of FIG. 1.

FIG. 4B illustrates an alternate cross-sectional view of a portion ofthe tissue opening closure device of FIG. 1.

FIG. 4C illustrates an alternate cross-sectional view of a portion ofthe tissue opening closure device of FIG. 1.

FIG. 4D illustrates an alternate cross-sectional view of a portion ofthe tissue opening closure device of FIG. 1.

FIG. 5 illustrates an exploded view of the tissue opening closure deviceof FIG. 1.

FIG. 6 illustrates a cross-sectional view of a portion of a needleactuation handle of the tissue opening closure device of FIG. 1.

FIG. 7 illustrates an isometric view of a locking member of the tissueopening closure device of FIG. 1

FIG. 8 illustrates a portion of a needle and suture anchor of the tissueopening closure device of FIG. 1.

FIG. 9 illustrates a cross-section view of a portion of a needle andsuture anchor of the tissue opening closure device of FIG. 1 in a firstposition.

FIG. 10 illustrates a cross-section view of a portion of a needle andsuture anchor of the tissue opening closure device of FIG. 1 in a secondposition.

FIGS. 11-21 illustrate a method for use of the tissue opening closuredevice so as to effect hemostasis.

FIG. 22 is an isometric view of a suture trimmer and knot replacementdevice in accordance with an embodiment of the present invention.

FIG. 23 is a partial cut-away isometric view of a suture trimmer andknot replacement device in accordance with an embodiment of the presentinvention.

FIG. 24 is a cross-sectional view of a portion of the suture trimmer andknot replacement device of FIG. 22.

FIG. 25 is an isometric view of a cutting member of the suture trimmerand knot replacement device of FIG. 22.

FIG. 26 is a partial isometric view of the distal tip of the suturetrimmer and knot replacement device in accordance with the presentinvention illustrating sutures disposed therethrough and the sutureretainer is in a retracted position.

FIG. 27 is a partial isometric view of the distal tip of the suturetrimmer and knot replacement device in accordance with the presentinvention illustrating sutures being disposed therethrough wherein thesuture retainer is in a deployed position.

FIG. 28 is a partial isometric view of the distal tip of the suturetrimmer and knot replacement device in accordance with the presentinvention illustrating sutures being disposed therethrough wherein thecutting member has been activated.

FIG. 29 is a partial view of the distal tip of the suture trimmer andknot replacement device in accordance with the present inventionillustrating sutures placed in a patient's tissue.

FIG. 30 is a partial view of the distal tip of the suture trimmer andknot replacement device in accordance with the present inventionillustrating sutures extending through the distal tip with the sutureretainer in a retracted position.

FIG. 31 is a partial view of the distal tip of the suture trimmer andknot replacement device in accordance with the present invention,wherein the suture trimmer and knot replacement device has been rotatedto twist the sutures together;

FIG. 32 is a partial view of the distal tip of the suture trimmer andknot replacement device in accordance with the present invention,wherein the sutures have been cut and the suture lock released.

FIG. 33 is a cross-sectional view of the alternate suture lock of FIG.32 in accordance with the present invention.

FIG. 34 is a cross-sectional view of another alternate suture lock inaccordance with the present invention.

FIG. 35 is a cross-sectional view of another alternate suture lock inaccordance with the present invention.

FIG. 36 is a cross-sectional view of another alternate suture lock inaccordance with the present invention.

FIG. 37 is a cross-sectional view of another alternate suture lock inaccordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The term “distal” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, as in the direction ofthe patient, or away from a user of a device, or in a case of arterialdeployment, in a direction of antegrade flow of blood. In the context ofa medical device intervention with or through a vessel wall, “distal”herein refers to the interior or the lumen side of the vessel wall. Inthe context of a medical device intervention with or through an openingin tissue, “distal” herein refers to the interior side of the tissue.

The term “proximal” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, as away from the patient,or toward the user, or in a case of arterial deployment, in a directionof retrograde flow of blood. In the context of a medical deviceintervention with or through a vessel wall, “proximal” herein refers tothe exterior or outer side of the vessel wall. In the context of amedical device intervention with or through an opening in tissue,“proximal” herein refers to the exterior side of the tissue.

The term “hemostasis” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, the arrest of bleeding orsubstantially blocking flow of blood outwardly from a vessel lumen whilethe vessel lumen is pressurized or sustaining physiological blood flow.This amount of blockage or occlusion to flow is further defined suchthat the blood loss which is experienced is less than an amount whichwould affect procedural methods or outcomes according to a physicianuser of a device of ordinary skill in the art. In other words,“hemostasis” is not intended to mean only “total hemostasis” such thatthere is a total lack of blood loss. Rather, the term is used to alsomean “procedural hemostasis” as a relative term in its use amongphysicians of ordinary skill.

The term “suturing” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, the process of joiningtwo surfaces or edges together with a fastener so as to close anaperture, opening, or wound or join tissues. The fastener is usually asuture such as a thread of material (either polymeric or natural), gut,wire or the like. The term “fastener” as used herein, is a broad termand is used in its ordinary sense, including, without limitation,clamps, studs, hasps, catches, hooks, rivets, staples, snaps, stitches,VELCRO, buttons, and other coupling members.

The term “pre-close” as used herein, is a broad term and is used in itsordinary sense, including, without limitation, the placement of thesutures in a blood vessel, e.g., femoral artery, before the arteriotomyis enlarged by an endovascular sheath.

One or more specific embodiments of the present disclosure will bedescribed below. In an effort to provide a concise description of theseembodiments, some features of an actual embodiment may be described inthe specification. It should be appreciated that in the development ofany such actual embodiment, as in any engineering or design project,numerous embodiment-specific decisions will be made to achieve thedevelopers' specific goals, such as compliance with system-related andbusiness-related constraints, which may vary from one embodiment toanother. It should further be appreciated that such a development effortmight be complex and time consuming, but would nevertheless be a routineundertaking of design, fabrication, and manufacture for those ofordinary skill having the benefit of this disclosure.

The present disclosure relates to methods, systems, and devices forclosing an opening in tissue, such as closing an opening or puncturethrough a wall of a body lumen. In one example embodiment, a closuresystem of the present disclosure may allow an operator to quickly andefficiently achieve hemostasis of an opening while simultaneouslyproviding the operator with a greater measure of control and flexibilityin positioning and anchoring portions of the closure system thanpreviously available. For example, the closure system may allow anoperator to achieve a more intimate securement of a closure element inthe tissue, such as tissue surrounding a body lumen opening. In a yetfurther embodiment, the closure system may be compatible with a widerrange of tissue structures and tissue thicknesses, such as body lumenwall thicknesses, thereby considering the possibility of calcificationsor scar tissue. In addition, the closure system can optionally beconfigured to advance into a body lumen opening over a guidewire. Inaddition, the closure system can be used to pre-close the tissueopening. Furthermore, the closure system may be compatible with avariety of sizes of body lumen openings and tissue tracts.

Referring now to FIG. 1, a closure device 10 generally has a shaft 12having a proximal end 14 and a distal end 16. A proximal housing 18supports a needle actuation handle 20 that is coupled to a plurality ofneedles 22 (FIG. 3) that can be advanced to penetrate tissue and deployanchored sutures. A flexible, atraumatic guidebody 24, with anatraumatic tip 26, extends from the distal end 16 of the shaft 12. Alock member 28 is disposed between the proximal housing 18 and theneedle actuation handle 20 to prevent inadvertent distal movement of theneedle actuation handle 20 to deploy the plurality of needles 22, thelock member 28 being tethered to the proximal housing 18, such as to oneof the finger grips 19. FIG. 1 illustrates the closure device 10 withthe lock member 28 in a first position preventing the inadvertent distalmovement before actuation and FIG. 2 illustrates the lock member 28 in asecond position so that movement of the needle actuation handle 20 inthe direction of the arrows advances the plurality of needles 22 (FIG.3). A biasing member 30 is positioned relative to the needle actuationhandle 20, such as on a portion of the needle actuation handle 20, toselectively maintain separation of the proximal housing 18 and theneedle actuation handle 20. The biasing member 30 provides resistance toneedle actuation handle 20 movement toward the proximal housing 18 andso provides enhanced control to the user. Additionally, the biasingmember 30 aids in retracting the needles 22 delivering the self-locatingsuture anchor 120 (FIG. 8) of the suture. The anchor 120 will have anexposed portion so that when the user releases the needle actuationhandle 20, the biasing member 30 will retract the needles 22 backthrough the vessel wall causing the exposed portion of the anchor 120(FIG. 5) to engage with the vessel wall and pulled off the needle 22 asthe needle 22 is retracted. Further details will be provided later.

As illustrated in FIGS. 1 and 3, disposed at the distal end 16 of theshaft 12 are needle ports 32 a, 32 b (anterior needle port 32 a andposterior needle port 32 b) to accommodate the plurality of needles 22and through which the needles 22 would extend to penetrate tissue. Theneedle ports 32 a, 32 b communicate with needle lumens 34 a, 34 b,illustrated in the cross-sectional view of FIG. 3, which extend from theproximal housing 18 to the needle ports 32 a, 32 b. The needles 22 canbe advanced distally to and through the needle ports 32 a, 32 b topenetrate tissue and also proximally to retrieve the needles 22.

The needle lumens 34 a, 34 b are positioned in a body 36 of the shaft12, the body 36 being covered with an outer sheath 38. As illustrated inFIGS. 3 and 4A, the needle lumens 34 a, 34 b are disposed on radiallyopposite sides of the body 36 with a guidewire lumen 40 and a markerlumen 42 being radially opposite each other at a location between theneedle lumens 34 a, 34 b. Positioning the needle lumens 34 a, 34 bradially opposite each other positions the needles 22 on an anterior andposterior side of the shaft 12, consistent with anterior and posteriorpositioning of the needles 22 relative to the opening through which theshaft 12 is advanced. It will be understood that the needle lumens 34 a,34 b, the guidewire lumen 40, and the marker lumen 42 and can be placedat other locations about the body 36, such as to achieve differentneedle puncture patterns, accommodate different target tissue within thepatient's anatomy, or to vary a delivery procedure to position theclosure device 10 in proximity to a tissue opening.

FIGS. 4B-4D illustrate a number of alternate locations and forms for theneedle lumens 34 a, 34 b and the guidewire lumen 40 within the body 36.For instance, FIG. 4B illustrates a plurality of needle lumens 34 a, 34b radially opposite each other on the anterior and posterior sides ofthe shaft 12, with the guidewire lumen 40 radially spaced from themarker lumen 42. The needle lumens 34 a, 34 b and guidewire lumen 40 arelumens having generally circular cross-sections and are spaced from anouter periphery of the body 36. In contrast, the marker lumen 42 isillustrated as a through hole, groove, recess, or channel formed in theouter periphery of the body 36. That said, the marker lumen 42 canalternatively be a lumen having a generally cross-section and be spacedfrom the outer periphery of the body 36. Additionally, and asillustrated in FIGS. 4C-4D, the needle lumens 34 a, 34 b and guidewirelumen 40 can also take the form of a through-hole, groove, recess, orchannel similar to the marker lumen 42 of FIGS. 4A-4B

In addition to the illustrated alternate configurations, it will beunderstood that the needle lumens 34 a, 34 b can be disposed beside eachother on one side, either anterior or posterior. Similarly, theguidewire lumen 40 and the marker lumen 42 can be disposed beside eachother on one side, either anterior or posterior. The needle lumens 34 a,34 b need not be separated by one or both of the guidewire lumen 40 andthe marker lumen 42 in a circumferential direction about a longitudinalaxis of the body 32.

Generally, the spacing of the needle lumens 34 a, 34 b or the spacing ofthe guidewire lumen 40 and the marker lumen 42 need not be about 180°.Instead, the spacing can be between about 5° to about 175° apart,between about 10° to about 165° apart, between about 20° to about 155°apart, between about 45° to about 135° apart. Additionally, while theneedle lumens 34 a, 34 b, the guidewire lumen 40, and the marker lumen42 can have a generally circular cross-section, alternate configurationsare possible. For instance, the cross-sections of the lumens can beelliptical, oval, polygonal, non-circular, or combinations thereof.

The guidewire lumen 40 accommodates a guidewire 46 upon which theclosure device 10 is advanced, whether by an over-the-wire or rapidexchange configuration. For instance, the guidewire lumen 40 can extendfrom an inlet port 50 at the atraumatic tip 26 to an exit port 52positioned proximal the needle actuation handle 20 of the closure device10. Alternatively, the guidewire lumen 40 can be formed on a smallsection of the guidebody 22 or the shaft 12, with both an input port 50and an exit port 52 being formed in the guidebody 22 or the shaft 12. Instill another configuration, the inlet port 50 can be disposed closer tothe inlet 56 of the bleed back passageway 54, as shown in phantom inFIG. 2, as inlet 50 a.

The marker lumen 42 forms part of a bleed back passageway 54 extendingfrom the guidebody 24 to the proximal housing 18. When an inlet port 56of the bleed back passageway 54 enters a body lumen, such as a bloodvessel, the pressure of the blood will cause blood to flow through inletport 56, along the passageway 54, and exit from the outlet port 58.Pulsating flow from the outlet port 58 indicates that the shaft 12 isappropriately positioned in the blood vessel. Instead of locating theinlet port 56 as illustrated in FIGS. 1 and 2, the inlet port can bedisposed closer to the needle ports 32 a, 32 b, as illustrated inphantom in FIG. 1, as inlet ports 56 a and 56 b.

The needle lumens 34 a, 34 b, the guidewire lumen 40, and the markerlumen 42 can be formed from one or more tubes provided in the shaft 12,proximal housing 18, and the guidebody 24. For instance, as shown inFIGS. 1, 2, and 5, at least a portion of the guidewire lumen 40 isformed by the guidewire tube 60 extending from a proximal end of theneedle actuation handle 20 and a guidewire tube 48 disposed within theguidebody 24, the guidewire tube 60 overlapping or being received withinthe guidewire tube 48 to form the guidewire lumen 40.

At least a portion of the marker lumen 42 is formed by the marker tube62 extending from the proximal housing 18. Optionally, at least portionsof the needle lumens 34 a, 34 b, the guidewire lumen 40, and the markerlumen 42 can be formed integrally with the body 36 of the shaft 12. Forinstance, the needle lumens 34 a, 34 b and the guidewire lumen 40 can beformed as the body 36 is extruded or otherwise formed. The marker lumen42 can be partially formed in the body 36 when extruded and closed uponsealing by connecting the outer sheath 38 to the body 36. In still otherconfigurations, the needle lumens 34 a, 34 b and the guidewire lumen 40can be formed in a similar manner to the marker lumen 42, such as theneedle lumens 34 a, 34 b and the guidewire lumen 40 being partiallyformed by the body 36 and closed or sealed when the outer sheath 38connects to the body 36.

Turning to FIGS. 5 and 6, the needles 22 and the needle actuation handle20 form a needle assembly 70 that can be advanced into and retractedfrom the proximal housing 18. This movement not only moves the needleactuation handle 20 but also a suture storage receptacle 72, andoptionally the guidewire tube 60, that extend from and are mounted tothe needle actuation handle 20. When the needle assembly 70 is removedfrom the proximal housing 18, a suture 66 is released from the suturestorage receptacle 72 as the suture storage receptacle 72 is slid overthe suture. Similarly, the guidewire tube 60 is slid over the guidewire46. Each length of suture 66 can be about 10.5 inches (26.7 cm) inlength. Alternatively, the suture can have a length from about 10 inches(25.4 cm) to about 15 inches (38.1 cm) of working length from anengagement surface of the suture anchor 120 (FIG. 5).

To aid with such movement, a body portion 78 of the needle actuationhandle 20 can be slidably received within an interior 80 of the proximalhousing 18. With the plurality of the needles 22 being guided in theirmovement by the needle lumens 34 a, 34 b, the body portion 78 can simplyslide within an opening 82 formed in the proximal housing 18. However,if additional control to the movement is desired, the body portion 78and a portion of the proximal housing 18 can be keyed together so thatrotational movement of the body portion 78 relative to the proximalhousing 18, or vice versa, can be limited.

To further control movement of the needle actuation handle 20 into andaway from the proximal using 18 in proximal-to-distal ordistal-to-proximal directions, the biasing member 30 provides resistanceto movement of the needle actuation handle 20 toward the proximalhousing 18 and so provides enhanced control to the user. The biasingmember 30, such as a spring, is positioned on the body portion 78between a handle portion 76 of the needle actuation handle 20 and aproximal end of the proximal housing 18. As the biasing member 30 iscompressed during proximal-to-distal movement of the handle portion 76,the biasing member 30 resists the movement. This provides enhancedtactile feel to the user, so needle penetration is more controlled. Thebiasing member 30 can have a generally uniform cross-section andapproximates an outer diameter of the body portion 78. Alternatively,the biasing member 30 can have a configuration where it providesincreased resistance as the proximal-to-distal translation of the handleportion 76 increases, i.e., the handle portion 76 moves closer to theproximal housing 18. This can be achieved, when the biasing member 30 isa spring, through increasing a diameter of the wires from the spring,changing a cross-section of the spring, or other manners know by thoseskilled in the art. It will also be appreciated that other biasingmembers can be used and may be adjusted to provide variable resistance.For instance, the spring force of the biasing member 30 may be linear ornon-linear. The biasing member 30 can have a higher density of coils ata distal end and lower density of coils at a proximal end allowing foran increase in resistive force as the handle portion 76 is advanced.This would reduce a needle speed of the needles 22 at an end of thestroke of the handle portion 76 as the vessel is pierced by the needles22. Additionally, detents (illustrated in phantom) could be provided ata proximal end and/or distal end of the body portion 78 to retain thebiasing member 30 so it does not become disengaged from the body portion78.

In addition to the biasing member 30 controlling movement of the needleactuation handle 20 relative to the proximal handle 18, the lock member28 prevents the inadvertent distal movement before actuation. Asillustrated in FIGS. 6 and 7, the lock member 28 at least partiallysurrounds the biasing member 30 and the body portion 78 of the needleactuation handle 30 and receives lipped structures 44, such as flangesor ledges, extending from the handle portion 76 and the proximal housing18. Those lipped structures 44 are received within complementary grooves96 formed within a channel 90 having a curved surface 92 and generallyplanar surfaces 94. The locking member 28 prevents the biased movementof the handle portion 76 relative to the proximal housing 18 under theforce of the biasing member 30 as the lipped structures 44 slide intothe grooves 96 as the locking member 28 is advanced transversely to alongitudinal axis of the proximal housing 18 and the needle actuationhandle 20. The lipped structures 44 can extend around the body portion78 and the opening 82 of proximal housing 18 in a circumferentialdirection as a continuous lipped structure or can include one or morediscrete spaced apart lipped structures.

While reference is made to including the lipped structures on thelocking member 28, it will be understood that the locking member canincluded other structures that capture or engage with the proximalhosing 18 and the needle actuation handle 20. For instance, optionally,extending from the planar surfaces 94 are detents 97 that providefrictional engagement with one or both of the biasing member 30 and thebody portion 78 of the needle actuation handle 30.

An outer surface 98 of the locking member 28 includes graspingstructures 100, such as grooves, slots, or other texturing, to aid withgrasping and manipulating the lock member 28 so a user can disengage thelock member 28. While an outer surface 98 generally mirrors the shape ofthe curved surface 92 and the planar surfaces 94, this need not be thecase and the outer surface 98 can have a variety of other shapes orconfigurations. Additionally, while reference is made to including thegrasping structures and detents, it will be understood that one or moreof the outer surface 98, the curved surface 92, and generally planarsurfaces 94 can include friction enhancing surfaces to aid with graspingby a user or being securely retained against the biasing member 30and/or the body portion 78.

Returning to FIG. 5, with removal of the lock member 28, the needleactuation handle 20 can move into and from the proximal handle 18,thereby moving the needles 22 through the needle port 32 a, 32 b topuncture tissue. This movement advances a distal end 110 of each needle22 and deploys a suture anchor 120 from each needle 22, as illustratedin FIGS. 8-10. The suture anchor 120 is partially retained within alumen 112 of the needle 22 and partially extends through a slot 114extending proximally from the distal end 110. The suture 66 attached toeach suture anchor 120 extends proximally within the lumen 112 of theneedle 22 to which the suture anchor 120 is selective attached. The legs122 of the suture anchor 120 bend proximally from a base 124, with thelegs 122 and the base 124 generally forming a T-shape. The legs 122 canrest, in one configuration, along an outer surface 116 of the needle 22,when the needle 22 is disposed within the needle lumen 34 a, 34 b. Thelegs 122 remain in this orientation as the needle 22 is advanced fromthe needle port 32 a, 32 b and through the tissue as a sharpened edge130 of the distal end 110. Once through the tissue, the legs 122 extendoutwardly and away from the outer surface 116, as illustrated in FIG. 9,returning to the general T-shape configuration. When the needleactuation handle 20 is moved proximally, frictional engagement of thesuture anchor 120 within the lumen 112 and slot 114 is overcome as thesuture anchor 120 is brought into contact with the tissue so that thesuture anchor 120 is deployed from the retracted needle 22.

The suture anchor 120 illustrated in FIGS. 8-10 can be fabricated frompolypropylene or another polymer. The legs 122 can be integrally formedwith the base 124 that is subsequently bonded to the suture 66. Forinstance, the base 124 can include an opening 126 providing access forthe suture 66 into a lumen 128. The suture 66 can be secured within thelumen 128, such as through thermal welding, adhesives, crimping,mechanical affixation, or other attachment techniques. Alternatively,the suture 66 and base 124 can be heated to reflow to form a one-piece,optionally monolithic, suture anchor and suture structure. In stillanother configuration, the legs 122, whether individually or as abar-like member forming both legs 122 in the illustrated configuration,can be heated to reflow to form a one-piece, optionally monolithic,suture anchor and suture structure, without the base 124. In this otherconfiguration where the suture anchor 120 does not include the base 124,the legs 122 can be secured to the suture 66 through thermal welding,adhesives, crimping, mechanical affixation, or other attachmenttechniques.

While reference is made to the legs 122 and the base 124 generallyforming a T-shape, it will be understood that other orientations arepossible. For instance, the legs 122 can form a V-shape, with theV-shape being open in the proximal direction and with or without thebase 124 extending from an apex in the open form. In anotherconfiguration, the legs 122 can form a U-shape being open in theproximal direction and with or without the base 124 extending from thecurved portion of the U-shape. In still another configuration, thesuture 66 is tied to the suture anchor 120, such as at an intermediateposition of the legs 122 when no base 124 is included. The knot providesa mechanical connection between the suture 66 and the suture anchor 120.To aid with maintaining the knot, it can be thermally set or can beheaded to at least partially reflow.

Turning to FIG. 11-21 illustrated is one method for closing a tissueopening or puncture using the closure device of the present invention.FIG. 11 illustrates first steps of a method for closing a puncture 150in a body wall 152. The method can begin following positioning aguidewire 46 through the skin 156 along the tissue tract 158 through thepuncture 150 in the body wall 152 and into the body lumen 154, such as avessel. With the guidewire 46 in place, the guidebody 24 is advancedover the guidewire 46, as illustrated in FIG. 11, until the guidebody 24is within the body lumen 154. The guidebody 24 is then retractedproximally until pulsating flow from the outlet port 58 indicates thatthe shaft 12 is appropriately positioned in the body lumen 154, asillustrated in FIG. 12.

Following positioning the shaft 12 within the body lumen 154, the lockmember 28 is disconnected from its engagement with the needle assembly70. More specifically, a user grasps the outer surface 98 and appliessufficient force to overcome the engagement between the detents 96 andthe biasing member 30 and/or the body portion 78. The lock member 28remains attached to the finger grips 19 of the proximal handle 18through the tether 102, as illustrated in FIG. 13, but no longerprevents inadvertent movement of the needle actuation handle 20.Instead, the user can advance the needle actuation handle 20 to begin toadvance the needles 22 from the needle ports 32 a, 32 b so that the legs122 extend generally transversely or perpendicularly to the suture in apre-deployed or partially deployed state. The needles 22 can then beadvanced into and through the tissue, as illustrated in FIGS. 14 and 15.

The legs 122 resiliently flex or deflect to extend proximally as theneedle 22 penetrates and passes through the body wall 152 on oppositesides of the puncture 150 and into the body lumen 154. Once in the bodylumen 154, as illustrated in FIG. 16, the legs 122 extend outwardly fromthe needle 22 and the suture anchor 120 moves to the deployed state withthe legs 122. The legs 122 extend generally transversely orperpendicularly to the suture as the force on the legs 122 as they movethrough the tissue is released and the resiliency of the materialforming the legs 122 allows the legs to transition to the deployedstate. Alternatively, the legs 122 can be biased toward the deployedstate, such as through forming the legs 122 with or including a biasingmember in the legs formed of NITINOL or other shape memory orsuperelastic material. Alternatively, the legs 122 can be formed ofMagnesium or some other biodegradable or bioabsorbable material.

As shown, the suture anchor 120 in the expanded state has a diameter orwidth greater than the width of the needle 22 or the opening in the bodywall 152 formed by the needle 22. This increased dimension preventspassage of the suture anchor 120 when the user pulls back on the needleactuation handle 20 and the legs 122 contact the body wall 152, asillustrated in FIGS. 17-19. Instead, following the initial contact withthe body wall 152, continued proximal movement of the needle actuationhandle 20 overcomes frictional engagement between the suture anchor 120and the slot 114, walls of the needle 22, and/or interior surface of thelumen 112 to release or allow detachment of the suture anchor 120 fromthe needle 22.

Referring now to FIG. 20, the needle assembly 70 is moved proximallythrough the shaft 12 and separated from the proximal handle 18. Thismovement also draws the sutures 66 from within suture storage receptacle72 leaving the sutures 66 extending from the suture anchor 120 throughthe shaft 12 and the proximal handle 18, as illustrated in FIGS. 20 and21. Thereafter, the closure device 10 can be removed while leaving theguidewire 46 in place to retain access to the puncture 150. The sutures66 from each suture anchor 120 can be tied together to create hemostasisand then the ends of the sutures 66 can be cut following confirmation ofhemostasis. This can be achieved directly by the clinician, surgeon, orthe like, manually forming, advancing the knot to the puncture 150, andthen cutting the suture 66. Alternatively, the clinician, surgeon, orthe like can use a knot pusher and suture cutter, such as the suturetrimmer disclosed in U.S. Pat. No. 8,211,123 entitled Suture Trimmer andthe snared suture trimmer disclosed in U.S. Pat. No. 6,746,457 entitledSnared Suture Trimer, the disclosures of which are is incorporated hereby this reference.

Instead of using a knot pusher and suture cutter, the present inventionalso contemplates use of a knot replacement device that holds sutures ina position to induce hemostasis without the sutures being tied into aknot. The knot replacement device uses a suture lock as a mechanicalstructure to prevent suture slippage following tensioning to causehemostasis. This provides for a quick and efficient mechanism to retainthe sutures to maintain hemostasis.

Referring now to FIGS. 22-24 there is shown an exemplary embodiment of aknot replacement device 200 in accordance with the present invention.The knot replacement device 200 comprises a shaft 210 having a proximalend 212 and distal end 214, with a handle 230 disposed at the proximalend 212 of the shaft 210. A suture lock 250 is disposed at the distalend 214 within an opening 216 communicating with a bore 218 of the shaft210. A cutting member 260 and an actuator member 270 are slidablydisposed within the bore 218 of the shaft 210, with the cutting member260 selectively closing an aperture 220 in a wall 222 of the shaft. Thecutting member 260 is adapted to cut the sutures 66, while the actuator270 can aid with deployment of the suture lock 250 from the shaft 210.

Generally, the knot replacement device 200 in accordance with thepresent invention is suitable for use in remote procedures performedthrough percutaneous tissue punctures, such as vascular closures,laparoscopic and other minimally invasive procedures and the like. Thus,the shaft 210 of the knot replacement device 200 may be embodied in manylengths to accommodate the various procedures for which the device maybe utilized. The diameter of the shaft 210 will be sufficiently small tofacilitate the introduction through access sheaths, trocars, and thelike, as well as punctures through the tissue of a patient's body,herein referred to as a “tissue tract, ” and/or coated with lubriciouscoatings such, as hydrophilic or hydrophobic coatings. Typically, thediameter of the shaft 210 will range from about 4 French to about 10French, more preferably the diameter of the shaft may range from about 6French to about 8 French.

It shall be appreciated that although the knot replacement device 200will be described as being utilized in minimally invasive procedures, itis contemplated that the knot replacement device 200 can be utilized formany open procedures that utilize sutures to close vessels or wounds.

The shaft 210 of the knot replacement device 200 in accordance with thepresent invention is preferably rigid, typically being formed from of abio-compatible material such as metal or plastic. Suitable metalsinclude stainless steel, gold plated metals, silver plated metals,platinum or platinum plated metals, or titanium. It shall be understoodthat other metals may be utilized if an appropriate bio-compatiblecoated was applied thereto. Suitable plastics include polycarbonate,polyvinyl chloride (PVC), nylon, or similar plastics. As will bedescribed in greater detail below, the shaft 210 may be formed of morethan one component. It is further contemplated that the shaft 210 may beconstructed to provide a degree of flexibility which will enable thedevice to be utilized in a greater number of surgical procedures.

The housing 230 may be constructed of a bio-compatible material such asmetal or plastic. Suitable metals include stainless steel, gold platedmetals, silver plated metals, platinum or platinum plated metals, ortitanium. It shall be understood that other metals may be utilized if anappropriate bio-compatible coated was applied thereto. Suitable plasticsinclude polycarbonate, polyvinyl chloride (PVC), nylon, or similarplastics. In a preferred embodiment the housing is constructed ofplastic.

In a preferred embodiment the suture lock 250 will be provided withinthe bore 218 at the distal end 214 of the shaft 210. The suture lock 250is preferably formed of a material that can firmly engage the suturesand prevent inadvertent slippage that would prevent hemostasis, whilealso being bio-compatible. For instance, the suture lock 250 isconstructed from the following or compounds of the following: polylacticacid (PLA), polyglycolic acid (PGA), polyglactin,polyepsilon-caprolactone, polydioxanone (PDS), polyorthoester, andpolyethylene oxide. A cross-section of the suture lock 250 can berounded, elliptical, oval, polygonal, non-circular or non-rounded, orcombinations thereof.

As illustrated in FIG. 24, the suture lock 250 has an opening 252extending through a proximal portion 254 and a distal portion 256. Theproximal portion 254 has a shape complementary to the opening 216. Forinstance, in the illustrated configuration, the proximal portion 254 hasa generally cylindrical form. In contrast, the distal portion 256 has aslightly convex or concave front face 258. The suture lock 250preferably has a diameter equal to or less than the diameter of theshaft 210 for one or both of the proximal portion 254 and the distalportion 256. In some circumstances, however, a distal end of the suturelock 250 can have a larger diameter than the shaft 210. The suture lock250 will further include the opening 252 formed through an axis thereofand in communication with the opening 216 formed the shaft 210. Theopening 252 also is in communication with the aperture 220 in the wall222 and has sufficient clearance so that the free ends and limbs of Sand S′ of the suture 66 may be drawn through the opening 252 and theaperture 220 through the use of a suture snare 290 (FIGS. 22-23). Thefree ends and limbs S and S′ of the suture 66 extend from the aperture220 in the shaft 210 and enable the tensioning of the suture 66, ifneeded.

The opening 252 can have a diameter that approximates and accommodatesfor any suture extrusion dimensional variation to assure interferencewhen the suture is wrapped. The opening 252 can include one or moreinternal grooves 259 that extend from the proximal portion 254 to thedistal portion 256 axially, non-axially, spirally, helically, orcombinations thereof. The grooves 259 allow for excess suture to bewedged during lock advancement. The grooves 259 can have uniform ornon-uniform depth along the groove's length. For instance, thenon-uniformity can be gradual between the proximal portion 254 to thedistal portion 256 or can be discontinuous, irregular, or intermittentalong the groove's length. Alternate examples of the openings of thesuture lock 250 are illustrated in FIGS. 32-36.

The suture lock 250 may be retained within a bore 218 of the shaft 210through the use of mechanical fasteners or suitable adhesives whilebeing selectively released from the shaft 220. As illustrated in FIG.24, the detents 224 can be formed on the shaft 210 to hold the suturelock 250. Alternatively, the shaft 210 can be crimped or deformed toform the detents 224 either before or after the suture lock 250 isdisposed within the opening 216. The detents 224 provide some resistanceto twisting or rotating of the suture lock 250 relative to the distalend 214 of the shaft 210, in addition to limiting longitudinal movement.By so doing, the suture lock 250 does not inadvertently release fromdistal end engagement while the sutures 66 are twisted or braidedtogether.

It will be understood that while reference is made to inclusion ofdetents, the shaft and suture lock can have various otherconfigurations. For instance, the suture lock can include acircumferential groove or independent holes or apertures that cooperatewith a detent. In still another configuration, the shaft can have aproximally tapering end that receives a proximal portion of the suturelock having sufficient pliability or deformability to being insertedthrough the opening into the tapering end and be retained therein untilreleased.

With reference to FIGS. 22-24, the cutting member 260 and the actuator270 may be retained within the bore 218 of the shaft 210 coaxially,though it is contemplated that they may be retained in other manners,such as, side-by-side or offset. Both the cutting member 260 and theactuator 270 are slidably disposed within the bore 218 of the shaft 210and can be actuated by a first lever 240 and second lever 242 extendingfrom the handle 230. The first lever 240 and second lever 242 areoperatively associated with the cutting member 260 and the actuatormember 270.

As shown in FIG. 25, the cutting member 260 comprises an elongatedmember 262 having a proximal end and a distal end 264. A cutting edge266 is formed within the cutting member 260 adjacent to the distal end264. The second lever 242 is coupled to the cutting member 260 adjacentto the proximal end. The lever 242 is further configured to engage abiasing member 232, such as a spring, within the handle 230, as shown inFIG. 23.

The cutting member 260 may be constructed of a bio-compatible material,such that the material chosen is capable of having a sufficiently sharpcutting edge 264 formed therein. For example, surgical stainless steelmay be utilized as well as titanium. Furthermore, it is contemplatedthat the cutting member 260 may include one or more elements coupledtogether. For example, the elongated member 262 of the cutting member260 may be constructed of a bio-compatible material such as plastic andthe sharp cutting edge 264 may be formed of metal, the cutting edge 264being mounted to the elongated member 262 to form a single structure.

The actuator 270 may be constructed of a bio-compatible material such asmetal or plastic. In a preferred embodiment the actuator 270 isconstructed of a bio-compatible plastic. Additionally, the actuator 270may be constructed of multiple pieces, wherein the actuator 270 andlever are assembled utilizing known methods of mechanical fastening orthrough the use of an adhesive. It is further contemplated that theactuator 270 and lever may be integrally formed or a one-piececonstruction, such as through the use of injection molding.

Referring now to FIGS. 26-28 there is shown a distal end of the knotreplacement device 200 in accordance with the present invention in use.As shown, the sutures 66 have the two free ends, S and S,′ those twoends S and S′ having been pulled through the suture lock 250 by thesuture snare 290. For instance, following placing the two free ends Sand S′ of the suture 66 within a distal end portion 292 of the suturesnare 290 that has been disposed through the opening 216, a housing 294of the suture snare 290 is detached from the shaft 210 (FIG. 23) andremoved, thereby allowing a user to draw the distal end portion 292,with the captured suture ends S and S′ through the opening 216 and thesuture lock 250. As the distal end portion 292 is drawn through opening218 and from the aperture 220, the free ends S and S′ are drawn throughto extend from the shaft 210.

With continued reference to FIGS. 26-28, there is shown the distal endof the knot replacement device 200 in accordance with the presentinvention. FIG. 26 illustrates the actuator 270 retracted to receive thesutures 66 through manipulation of the first lever 240 proximally. Whenthe first lever 240 is released, the biasing member 232 coupled to theproximal end of the actuator 270, causes the actuator 270 to advancedistally and partially closing the bore 218 adjacent the aperture 220,as illustrated in FIG. 27. A secondary biasing member 236, such as aspring, distal a distal end of the first lever 240 limits distalmovement of the actuator 270 until the suture lock 250 is to be deployedfrom the shaft 210. The biasing force of the secondary biasing member236 can be overcome through distal movement of the first lever 240 todistally advance the distal end of the actuator 270 against the proximalportion 254 to release it from, in one example, engagement with thedetent 224, or other rotational and/or longitudinal movement limiter.

As shown, the actuator 270 includes a groove 272 within which thesutures 66 can be disposed to protect the sutures 66 from inadvertentcutting by the edges of the aperture 220. If the suture 66 were allowedto contact the edge of the aperture 220, a nick or cut may be formed inthe sutures 66, this may lead to failure of the sutures 66 duringtensioning and before the suture lock 250 can be placed appropriately.If the sutures were to fail the clinician, surgeon, or the like would berequired to place additional sutures. Therefore, the actuator 270prevents the suture from being cut or abraded by the edge of theaperture 220 which may lead to failure of the suture.

Referring now to FIG. 28, there is shown a partial view of the distalend of the knot replacement device 200 in accordance with the presentinvention where the cutting member 260 has been actuated to cut thesutures. For instance, with the sutures 66 captured by the actuator 270the knot replacement device 200 is rotated to tension the sutures andcreate hemostasis of the puncture. This also braids or twists thesutures 66 together. When the braided or twisted portion is drawing intoa lumen 256 of the suture lock 250, sufficient frictional contact withthe sutures 66 occurs to prevent suture slippage and releasing of thetensions.

Upon actuation, the cutting edge 264 is advanced from a shieldedposition within the shaft 210 toward the sutures 66 through manipulatingthe lever 242. The cutting member 260 is advanced from the shieldedposition by applying a force to the lever 242, the lever 242 beingcoupled to the proximal end of the cutting member 260. As describedabove, the cutting member 260 is actuated by pulling back on the lever242, thereby advancing the lever 242 towards the proximal end of theknot replacement device 200 and compressing a second biasing member 234disposed within the handle 230. As shown, the cutting member 260includes the sharpened cutting edge 266 that cooperates with a distalend of the aperture to shear or cut the sutures 66. As described aboveand illustrated in FIG. 28, the cutting member 260 of the knotreplacement device 200 moves relative to the shaft 210.

Referring now to FIGS. 29-32, there is shown a partial view of thedistal end 214 of the knot replacement device 200 in accordance with thepresent invention disposed in various states of use associated with amethod of the present invention.

Referring now to FIG. 29, there is shown the distal end of the knotreplacement device 200 with the actuator 270 disposed in a distallyadvanced position. Sutures 66 have been positioned in tissue as shown,wherein the two free ends S and S′ of the sutures 66 extend from thetissue. In this position the knot replacement device 200 is ready toreceive the sutures 66 when the suture snare 290 (FIG. 22) draws the twofree ends S and S′ through the lumen 256 of the suture lock 250 and fromthe aperture 220 in the wall 222, as illustrated in FIG. 30.

Once the sutures 66 are positioned to extend through the aperture 220,the force applied to the first lever 240 (FIG. 22) is released, therebyallowing the actuator 270 to advance distally within the bore 218 of theshaft 210. The distal end of the actuator 270 passes the distal end ofthe aperture 220 but remains proximal to the proximal portion 254 of thesuture lock 250, as illustrated in FIG. 30.

With the sutures 66 locked in position through positioning of theactuator 270, the knot replacement device 200 is rotated to twist orbraid the sutures 66 together. This can include one or more full orpartial rotations until the sutures 66 have a cross-sectional dimensionthat is sufficient to frictionally engage with the opening 252. Forinstance, in one configuration the opening 252 has a diameter thatreceives two sutures and approximates and accommodates for any sutureextrusion dimensional variation to assure interference when the sutureis wrapped.

When sufficient twisting or braiding has occurred, an axial force isapplied to the second lever 242 to distally advance the cutting member260 to cut or sever the sutures 66. Additionally, either simultaneouslywith, or following movement of the cutting member, the first lever 240is moved distally, overcoming the biasing force of the secondary biasingmember 236, so that the distal end of the actuator 270 contacts theproximal portion 254 of the suture lock 250. Continued distal movement,distally advances the suture lock 250 from the distal end 215 of theshaft 210 to overcome the engagement forces between the detent 224 andthe suture lock 250, for instance, as illustrated in FIG. 32. Theengagement force is less than the anchor suture attachment force, whichis about 2 lbf. The engagement force, therefore, is about 0.5 to about1.25 lbf.

Turning to FIGS. 33-37, illustrated are different configurations of thesuture lock according to the present invention. Like reference numeralsare associated with like elements. Additionally, the disclosure of thesuture lock 250 is applicable to the suture locks illustrated in FIGS.33-37. For instance, openings in the suture locks of FIGS. 33-37 canhave a diameter that approximates and accommodates for any sutureextrusion dimensional variation to assure interference when the sutureis wrapped. The openings can include internal grooves that extend fromthe proximal portion to the distal portion axially, non-axially,spirally, helically, or combinations thereof. The grooves allow forexcess suture to be wedged during lock advancement. The grooves can haveuniform or non-uniform depth along the groove's length, such as gradualor discontinuous, irregular, or intermittent depth non-uniformitybetween the proximal portion and the distal portion.

With reference to FIG. 33, illustrated is a suture lock 350 a having anopening 352 a. The opening 352 a includes one or more grooves 359 adisposed around the periphery of the opening 352 a. The grooves 359 ainclude a curved wall 374 a extending from an inner wall 376 a of theopening 352 a in a radial direction, the inner wall 376 a forming aninner periphery 378 a of the opening 352 a and the outer periphery ofthe curved wall 374 a, in the radial direction, forming an outerperiphery 380 a of the opening 352 a.

FIG. 34 illustrates another suture lock 350 b having an opening 352 b.The opening 352 b includes one or more grooves 359 b disposed around theperiphery of the opening 352 b. The grooves 359 b includes a wall 374 bextending from an inner wall 376 b of the opening 352 b in the radialdirection, the inner wall 376 b forming an inner periphery 378 b of theopening 352 b and an apex of the wall 374 b forming an outer periphery380 b of the opening 352 b.

FIG. 35 illustrates another suture lock 350 c having an opening 352 c.The opening 352 c includes one or more grooves 359 c disposed around theperiphery of the opening 352 c. The grooves 359 c includes a curved wall374 c extending radially inwardly from an outer wall 376 c of theopening 352 c, the innermost periphery of the curved wall 374 c formingan inner periphery 378 c of the opening 352 b and the outer wall 376 cforming an outer periphery 380 c of the opening 352 c.

FIG. 36 illustrates another suture lock 350 d having an opening 352 d.The suture lock 350 d is similar to suture lock 350 a, however, thegrooves 359 d have differing depths in a radial direction and differingwidth in a circumferential direction.

FIG. 37 illustrates another suture lock 350 e having an opening 352 e.The suture lock 350 e is similar to suture lock 350 a, however, theopening 352 e is non-circular in that the opening 352 e has a long axis382 e and a short axis 384 e such that the opening 352 e approximate anoblong or rectangular shape with the grooves 359 e. While reference ismade to approximating an oblong or rectangular shape, the opening canhave other polygonal, elliptical, or other non-polygonal shapes so longas there is a long axis and a short axis, even if there is no symmetryabout one or both of the long axis and the short axis.

It is understood that any of the structures and features of embodimentsillustrated in FIGS. 33-37 can be combined into a single suture lock.Generally, each suture lock can include an opening and grooves, withsuch opening approximating any polygonal, elliptical, or othernon-polygonal shape and such grooves having the same or differentdepths, widths, and shapes in the suture lock and being uniformly ornon-uniformly distributed about the periphery of the suture lock.

The articles “a,” “an,” and “the” are intended to mean that there areone or more of the elements in the preceding descriptions. The terms“comprising,” “including,” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements. Additionally, it should be understood that references to “oneembodiment” or “an embodiment” of the present disclosure are notintended to be interpreted as excluding the existence of additionalembodiments that also incorporate the recited features. Numbers,percentages, ratios, or other values stated herein are intended toinclude that value, and also other values that are “about” or“approximately” the stated value, as would be appreciated by one ofordinary skill in the art encompassed by embodiments of the presentdisclosure. A stated value should therefore be interpreted broadlyenough to encompass values that are at least close enough to the statedvalue to perform a desired function or achieve a desired result. Thestated values include at least the variation to be expected in asuitable manufacturing or production process, and may include valuesthat are within 5%, within 1%, within 0.1%, or within 0.01% of a statedvalue.

A person having ordinary skill in the art should realize in view of thepresent disclosure that equivalent constructions do not depart from thespirit and scope of the present disclosure, and that various changes,substitutions, and alterations may be made to embodiments disclosedherein without departing from the spirit and scope of the presentdisclosure. Equivalent constructions, including functional“means-plus-function” clauses are intended to cover the structuresdescribed herein as performing the recited function, including bothstructural equivalents that operate in the same manner, and equivalentstructures that provide the same function. It is the express intentionof the applicant not to invoke means-plus-function or other functionalclaiming for any claim except for those in which the words ‘means for’appear together with an associated function. Each addition, deletion,and modification to the embodiments that falls within the meaning andscope of the claims is to be embraced by the claims.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately,” “about,” and “substantially” may refer to an amountthat is within less than 5% of, within less than 1% of, within less than0.1% of, and within less than 0.01% of a stated amount. Further, itshould be understood that any directions or reference frames in thepreceding description are merely relative directions or movements. Forexample, any references to “up” and “down” or “above” or “below” aremerely descriptive of the relative position or movement of the relatedelements.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the invention is, therefore, indicatedby the appended claims rather than by the foregoing description, with itbeing understood that the scope of the present disclosure extends torewriting any of the claims to depend from any other claim, to includemultiple dependencies from any combination of other claims, and/or tocombine multiple claims together. Additionally, elements described inrelation to any embodiment depicted and/or described herein may becombinable with elements described in relation to any other embodimentdepicted and/or described herein. Such also extends to the embodimentsas described in the Summary section, as well as the Detailed Descriptionsection, including the drawings. The scope of the present disclosurealso extends to inserting and/or removing any combination of featuresfrom any claim or described embodiment, for insertion into another claimor embodiment, or drafting of a new claim including any combination ofsuch features from any other claim(s) or embodiments. All changes whichcome within the meaning and range of equivalency of the claims are to beembraced within their scope.

What is claimed is:
 1. A closure device for closing an opening in tissueas part of a closure system, the closure device comprising: a needleactuation handle cooperating with a housing; a first hollow needleselectively movable by the needle actuation handle, the first hollowneedle comprising a slot extending proximally from a distal end of thefirst hollow needle; a suture anchor frictionally engaged with the slotand a lumen of the first hollow needle and coupled to a suture, aportion of the suture anchor resting along an outer surface of the firsthollow needle as the first hollow needle is advanced through tissueadjacent the opening.
 2. The closure device of claim 1, furthercomprising a locking member selectively disposed about a body of theneedle actuation handle distal a handle portion.
 3. The closure deviceof claim 2, wherein the needle actuation handle is biased proximallyfrom the housing.
 4. The closure device of claim 3, further comprising asecond hollow needle, the first hollow needle begin configured to exit afirst port of the housing and the second hollow needle being configuredto exit a second port of the housing.
 5. The closure device of claim 4,wherein the first port is proximal the second port.
 6. The closuredevice of claim 1, further comprising a shaft extending from thehousing, the shaft comprising at least one of a guidewire lumen, asuture lumen, and a marker lumen.
 7. The closure device of claim 1,wherein the suture anchor comprises two legs extending transversely tothe suture in the pre-deployed state and a deployed state.
 8. A closuresystem for closing an opening in tissue, the closure system comprising:a closure device comprising: a housing; a needle actuation handlecooperating with the housing; a first hollow needle selectively movableby the needle actuation handle, the needle comprising a slot extendingproximally from a distal end of the first hollow needle andcommunicating with a lumen of the first hollow needle that is configuredto receive a suture; and a suture anchor frictionally engaged with theslot and a lumen of the first hollow needle and coupled to a suture, aportion of the suture anchor resting along an outer surface of the firsthollow needle as the first hollow needle is advanced through tissueadjacent the opening; and a knot replacement device configured toposition a suture lock on the suture.
 9. The closure system of claim 8,further comprising a suture storage receptacle configured to receive aportion of the suture.
 10. The closure system of claim 8, furthercomprising a locking member selectively disposed about a body of theneedle actuation handle distal a handle portion, wherein the lockingmember slidable cooperates with a portion of the needle actuationhandle.
 11. The closure system of claim 10, wherein the locking membercomprises a groove to accommodate a complementary structure of theneedle actuation handle.
 12. The closure system of claim 8, wherein theneedle actuation handle and the first hollow needle are selectivelyslidable in both a proximal-to-distal direction and a distal-to-proximaldirection,
 13. The closure system of claim 8, with the needle actuationhandle and the needle being selectively removable from the housing. 14.The closure system of claim 8, further comprising a guidewire lumenextending proximally adjacent to a suture storage receptacle configuredto receive a portion of the suture.
 15. A method comprising: positioninga distal end of a closing device through a tissue opening, the closingdevice comprising a housing from which a first hollow needle isadvanceable; advancing the first hollow needle from the housing towardstissue adjacent to the tissue opening, the first hollow needlecomprising a suture anchor frictionally engaged with a slot and a lumenof the first hollow needle and coupled to a suture, the suture anchorcomprising two legs; and advancing the first hollow needle through thetissue adjacent to the tissue opening, the two legs resting along anouter surface of the first hollow needle as the first hollow needle isadvanced through tissue adjacent the opening.
 16. The method of claim15, further comprising proximally retracting the first hollow needlefollowing advancing the first hollow needle through the tissue toovercome the frictional engagement between the suture anchor and wallsof the slot and the lumen.
 17. The method of claim 16, furthercomprising capturing the suture following removable of the closingdevice with a knot replacement device.
 18. The method of claim 17,further comprising twisting the suture.
 19. The method of claim 18,following twisting the suture, advancing a suture lock on the suture,the suture lock comprises at least one groove to aid with capturing andsecuring the suture.
 20. The method of claim 19, further comprisingcutting the suture.